| Trial ID: | L7121 |
| Source ID: | NCT00574405
|
| Associated Drug: |
Mdi (Split-Mix Nph Insulin + Regular Insulin Or Lantus + Novolog® [Or Humalog®])
|
| Title: |
Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
|
| Acronym: |
ktpump
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00574405/results
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])|DEVICE: CSII (Animas Corporation insulin pump, model IR 1200)
|
| Outcome Measures: |
Primary: Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI., 12 months | Secondary: Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment., 12 months|Changes in Daily Insulin Requirements Over Time, 12 months|Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis., 12 months|Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations., 12 months
|
| Sponsor/Collaborators: |
Sponsor: Arkansas Children's Hospital Research Institute
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-04
|
| Completion Date: |
2011-03
|
| Results First Posted: |
2011-08-09
|
| Last Update Posted: |
2017-09-13
|
| Locations: |
Arkansas Children's Hospital/Research Institute, Little Rock, Arkansas, 72202, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00574405
|
